Evidence map›Paper›PMID 31815658›Full record

Trial reportTrials2019

A pragmatic pilot phase II randomised controlled trial of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) in adult patients who are undergoing heart surgery (PROPHESY).

Laura Green, Neil Roberts, Jackie Cooper, Jane Field, Ravi Gill, Andrew Klein, Seema Agarwal, Simon Stanworth, Atholl Johnston, Vivienne Monk and 1 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIComparative StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03715348 phase2completednot on this map

A Pragmatic Pilot Randomised Phase II Controlled Trial of Prothrombin Complex Concentrates (PCC) Versus Fresh Frozen Plasma (FFP) in Adult Patients Who Are Undergoing Heart Surgery

TypeinterventionalSponsorQueen Mary University of LondonRan2019 to 2020Enrolled50ConditionsBleeding, Surgery, TransfusionArmsProthrombin Complex Concentrate (PCC), Fresh Frozen Plasma
NCT04244981 phase4terminatednot on this mapstarted 2023, after this paper: background citation

Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery, Compared With Fresh Frozen Plasma: Study Protocol for a Non-inferiority, Randomized Controlled Trial

TypeinterventionalSponsorSHI JiaRan2023 to 2025Enrolled476ConditionsValvular Heart SurgeryArmsProthrombin Complex Concentrate, Human, Fresh Frozen Plasma
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Laura GreenBlizard Institute, Queen Mary University of London, NHS Blood and Transplant and Barts Health NHS Trust, 4 Newark Street, Whitechapel, London, E1 2AT, UK. laura.green@qmul.ac.uk.ORCID http://orcid.org/0000-0003-4063-9768
Neil RobertsSt Bartholomew's Hospital, West Smithfield, London, EC1A 7BE, UK.
Jackie CooperBarts Cardiovascular Clinical Trials Unit (CVCTU), William Harvey Research Institute, Heart Centre, Barts and The London School of Medicine, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK.
Jane FieldBarts Cardiovascular Clinical Trials Unit (CVCTU), William Harvey Research Institute, Heart Centre, Barts and The London School of Medicine, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK.
Ravi GillSouthampton General Hospital, Tremona Road, Southampton, SO16 6YD, UK.
Andrew KleinPapworth Hospitals NHS Foundation Trust, Papworth Everard, Cambridge, CB23 3RE, UK.
Seema AgarwalManchester Royal Infirmary, Oxford Road, Manchester, M13 9WL, UK.
Simon StanworthOxford University Hospitals NHS Foundation Trust, Headley Way, Oxford, OX3 9BQ, UK.
Atholl JohnstonWilliam Harvey Research Institute, Heart Centre, Barts and The London School of Medicine, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK.
Vivienne MonkBarts Cardiovascular Clinical Trials Unit (CVCTU), William Harvey Research Institute, Heart Centre, Barts and The London School of Medicine, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK.
Ben O'BrienSt Bartholomew's Hospital, West Smithfield, London, EC1A 7BE, UK.

Funding

British Heart Foundation 33368British Heart Foundation PG/17/82/33368Medical Research Council MC_PC_14089
6 · The paper itself

Abstract

backgroundFresh frozen plasma (FFP) is the accepted standard treatment for clotting factor replacement in bleeding patients during or immediately after cardiac surgery. In the United Kingdom prothrombin complex concentrate (PCC) is not licensed in this setting, although it is being used in Europe because it has a higher concentration of clotting factor levels, and it can be administered rapidly and in small volume, resulting in less volume overload during cardiac surgery.

methodsPROPHESY is a pragmatic, single-centre, open-label, randomised, controlled pilot trial that will assess whether it is feasible to perform a large trial in the future that will compare PCC versus FFP in patients who are bleeding (not on warfarin) and who require blood transfusion. Over a 15-month period, 50 patients will be randomised to PCC versus FFP if they develop active bleeding within 24 h of cardiac surgery and for whom the clinician has decided to administer FFP for treatment of bleeding. Standard laboratory and point-of-care assessments will be performed as per routine practice, and additional research blood samples will be taken at three time points to assess haemostasis. Subjects will be assessed daily up to hospital discharge or 30 days or death (whichever occurs first) and will be seen in follow-up for 90 days after surgery to assess for thromboembolic complications and hospital re-admission since discharge. Quality-of-life assessment will be performed pre-surgery and at 90 days post-surgery. We will also perform qualitative research with clinical experts and patients to explore the understanding of and experience with the interventions, as well as adherence to study procedures and protocol. DISCUSSION: There have been no randomised controlled trials that have compared the safety and efficacy of FFP versus PCC in cardiac surgery patients who are bleeding. This pilot study will assess if individual components of a large trial are deliverable to assess the safety and efficacy of the two blood products in the future.

trial registrationEudraCT, 2018-003041-41; ClinicalTrials.gov, NCT03715348. Registered on 29 July 2018.

Indexed as

PlasmaAdultBlood Coagulation FactorsCardiac Surgical ProceduresHumansPilot ProjectsQuality of LifeSample SizeBlood Coagulation Factorsprothrombin complex concentratesBleedingCardiac surgeryFresh frozen plasmaPilot studyProthrombin complex concentrateRandomised controlled trial

Identifiers

PMID31815658
PMCPMC6902595

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.